Senior Quality Assurance Specialist

6 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $87,400 - $129,324
Quality Assurance Professional

This is an exciting opportunity for a highly motivated and proactive Quality Assurance professional to join our team.

Key responsibilities include:

  • Maintaining good knowledge of the ISO9001 Standard and ensuring compliance with relevant government regulations.
  • Reviewing and approving scientific content of new registration packages prior to submission to regulatory authorities.
  • Managing Quality Management System activities, including internal auditing, management review, CAPA, training, supplier qualification and management.
  • Coordinating and implementing product actions, such as Field Actions and Product Information.

Requirements:

  • Science or pharmacy degree.
  • 12-18 months experience in Regulatory and/or Quality experience, preferably with diagnostics experience.
  • Exposure to Regulatory and/or Quality in a Pathology laboratory setting will be considered.
  • Experience and knowledge of ISO9001.
  • Excellent communication skills and ability to build respectful relationships with stakeholders.
  • Hunger to learn and take initiative.

Benefits:

  • Free parking and on-site gym facilities.
  • Discounted Shares program.
  • Wellness programs.
  • Professional development opportunities.
  • Part of a World's Top Employer recognized for workplace culture values.
Why You'll Love This Role
  • Opportunity to grow professionally and personally.
  • Chance to work with a diverse range of stakeholders.
  • Dynamic and supportive work environment.

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